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An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. (ECLIPSE)

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ClinicalTrials.gov Identifier: NCT01908816
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Macular Edema Glaucoma, Neovascular Diabetic Retinopathy Drug: ranibizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Study Start Date : September 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: ranibizumab Drug: ranibizumab
One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)




Primary Outcome Measures :
  1. Rate and severity of serious and non-serious, ocular and non-ocular adverse events [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Average change of BCVA for patients with CNV and ME [ Time Frame: 3 months ]
    BCVA will be tested using the ETDRS, the Snellen or Monoyer scales. VA measurements will be preferentially taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score will be calculated using the BCVA worksheet which will be kept in the source data and the score will be recorded in the eCRF. ETDRS, Snellen and Monoyer VA measurements will be transformed in logMAR to be analyzed.

  2. Average change of neovascularization extension for patients with neovascular glaucoma [ Time Frame: 3 months ]
    Change of the extent of iris neovascularization using "Teich and Walsh grading system" using iris photography

  3. Proportion of patient with Vitreous Cavity Hemorrhage occurrence for patient with proliferative retinopathy [ Time Frame: 3 months ]
    Occurrence of postoperative vitreous cavity hemorrhage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active choroidal neovascularization (CNV)
  • Active macular edema (ME)
  • Rubeosis iridis/neovascular glaucoma.
  • Proliferative diabetic retinopathy requiring vitrectomy.

Exclusion Criteria:

  • wet Age-related macular degeneration
  • pathologic myopia
  • pseudoxanthoma elasticum
  • diabetic macular edema
  • retinal vein occlusion
  • < 18 years of age
  • History of hypersensitivity to ranibizumab
  • Use of any systemic anti-angiogenic drugs 3 months before inclusion
  • Women of child-bearing potential and Pregnant or nursing (lactating) women.
  • Active or suspected ocular infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908816


Locations
France
Novartis Investigative Site
Amiens Cedex 1, France, 80054
Novartis Investigative Site
Angers, France, 49044
Novartis Investigative Site
Bobigny, France, 93009
Novartis Investigative Site
Bordeaux, France, 33000
Novartis Investigative Site
Bordeaux, France, 33100
Novartis Investigative Site
Caen, France, 14050
Novartis Investigative Site
Créteil, France, 94000
Novartis Investigative Site
Ecully, France
Novartis Investigative Site
Grenoble, France, 38000
Novartis Investigative Site
Grenoble, France, 38043
Novartis Investigative Site
Lille, France, 59000
Novartis Investigative Site
Lyon Cedex 04, France, 69317
Novartis Investigative Site
Lyon, France, 69275
Novartis Investigative Site
Mantes la jolie, France, 78201
Novartis Investigative Site
Marseille Cedex 8, France, 13008
Novartis Investigative Site
Marseille, France, F-13008
Novartis Investigative Site
Melun, France, 77000
Novartis Investigative Site
Montauban, France, 82000
Novartis Investigative Site
Montpellier, France, 34000
Novartis Investigative Site
Mulhouse cedex, France, 68070
Novartis Investigative Site
Nantes Cedex 1, France, 44093
Novartis Investigative Site
Nice, France, 06000
Novartis Investigative Site
Paris cedex 10, France, 75010
Novartis Investigative Site
Paris Cedex 19, France, 75940
Novartis Investigative Site
Paris, Cedex 12, France, F-75571
Novartis Investigative Site
Paris, France, 75006
Novartis Investigative Site
Paris, France, 75007
Novartis Investigative Site
Paris, France, 75013
Novartis Investigative Site
Paris, France, 75014
Novartis Investigative Site
Paris, France, 75015
Novartis Investigative Site
Poitiers, France, 86021
Novartis Investigative Site
Rouen, France, 76100
Novartis Investigative Site
Saint-Jean, France, 31240
Novartis Investigative Site
Saitnt Herblain, France, 44819
Novartis Investigative Site
St-Priest-en-Jarez, France, 42270
Novartis Investigative Site
Strasbourg Cedex, France, 67091
Novartis Investigative Site
Toulouse, France, 31077
Novartis Investigative Site
Tours, France, 37000
Novartis Investigative Site
Tours, France, 37044
Novartis Investigative Site
Vannes, France, 56000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01908816     History of Changes
Other Study ID Numbers: CRFB002GFR02
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Macular Edema
Diabetic Retinopathy
Neovascularization, Pathologic
Choroidal Neovascularization
Glaucoma, Neovascular
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Glaucoma
Ocular Hypertension
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents